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The Evolving Role of In Vitro-In Vivo Correlation in Model-Informed Drug Development: A Multi-Stakeholder
Marylore Chenel1, Sylvain Fouliard2, Emma Hansson1
1Pharmetheus AB, Uppsala, Sweden.
Physiologically based biopharmaceutics modeling (PBBM) and in vitro-in vivo correlation (IVIVC) models are vital for predicting drug performance. This review explores challenges and opportunities for their enhanced application in pharmaceutical development and regulatory science.
Area of Science:
- Pharmaceutical Sciences
- Biopharmaceutics
- Regulatory Science
Background:
- In vitro-in vivo correlation/relationship (IVIVC/R) models, including physiologically based biopharmaceutics modeling (PBBM), are essential for connecting drug properties to clinical outcomes.
- These models streamline drug development, minimize experimental costs, and support regulatory submissions for formulation-based inquiries.
Purpose of the Study:
- To consolidate current insights on IVIVC/R and PBBM from academia, industry, and service providers.
- To explore future opportunities, organizational challenges, regulatory viewpoints, and skill gaps related to these modeling approaches.
Main Methods:
- Literature review and synthesis of expert opinions.
- Analysis of current applications and future trends in pharmaceutical development.
Main Results:
- Identification of key areas for enhanced application of IVIVC/R and PBBM.
- Discussion of organizational and regulatory hurdles impacting widespread adoption.
- Highlighting of critical competency gaps within the pharmaceutical industry.
Conclusions:
- Further integration of IVIVC/R and PBBM can significantly advance pharmaceutical development and regulatory decision-making.
- Addressing identified challenges and investing in skill development are crucial for maximizing the potential of these predictive tools.
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